Dressing, Wound, Drug

Device Code: 5919

Product Code(s): FRO

Device Classification Information

Device Type ID5919
Device NameDressing, Wound, Drug
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type510(k)
FDA Device ClassificationClass Unclassified Medical Device
Product CodeFRO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5919
DeviceDressing, Wound, Drug
Product CodeFRO
Premarket Reviews
ManufacturerDecision
3-D MATRIX, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
3M COMPANY
 
SUBSTANTIALLY EQUIVALENT
 2
3M COMPANY, 3M HEALTH CARE
 
SUBSTANTIALLY EQUIVALENT
 1
ABIGO MEDICAL AB
 
SUBSTANTIALLY EQUIVALENT
 2
ABL MEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
ADVANCED MEDICAL SOLUTIONS GROUP PLC
 
SUBSTANTIALLY EQUIVALENT
 3
ARGENTUM MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 3
ARGENTUM MEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
AVERY DENNISON CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 4
B. BRAUN MEDICAL INC.
 
SUBSTANTIALLY EQUIVALENT
 2
B. BRAUN MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
BEEKEN BIOMEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
BENQ MATERIALS CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 2
BIO-MEDICAL CARBON TECHNOLOGY CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
BIOTD, S.A.
 
SUBSTANTIALLY EQUIVALENT
 3
BSN MEDICAL GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
COAG MEDICAL LLC
 
SUBSTANTIALLY EQUIVALENT
 1
CONVATEC INC.
 
SUBSTANTIALLY EQUIVALENT
 2
CONVATEC LIMITED
 
SUBSTANTIALLY EQUIVALENT
 2
CORE SCIENTIFIC LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
CORELEADER BIOTECH CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
CRYOLIFE, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
DERMA SCIENCES CANADA, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
DEROYAL
 
SUBSTANTIALLY EQUIVALENT
 2
DEROYAL INDUSTRIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
DYNAREX
 
SUBSTANTIALLY EQUIVALENT
 1
ENTROTECH LIFE SCIENCES INC.
 
SUBSTANTIALLY EQUIVALENT
 1
EXCITON TECHNOLOGIES INC.
 
SUBSTANTIALLY EQUIVALENT
 2
GLYCOBIOSCIENCES, INC
 
SUBSTANTIALLY EQUIVALENT
 3
HELSINN HEALTHCARE SA
 
SUBSTANTIALLY EQUIVALENT
 1
HEMCON MEDICAL TECHNOLOGIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
 
SUBSTANTIALLY EQUIVALENT
 1
HUIZHOU FORYOU MEDICAL DEVICES CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 4
HYDROFERA, LLC.
 
SUBSTANTIALLY EQUIVALENT
 1
IMBED BIOSCIENCES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
INNOTHERAPY INC.
 
SUBSTANTIALLY EQUIVALENT
 1
INTEGRA LIFESCIENCES CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 2
INVADO PHARMACEUTICALS LLC
 
SUBSTANTIALLY EQUIVALENT
 1
ISDIN CORP
 
SUBSTANTIALLY EQUIVALENT
 1
LABORATOIRES URGO
 
SUBSTANTIALLY EQUIVALENT
 1
LINKDICAL PRODUCTS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
LINKS MEDICAL PRODUCTS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
MANUKA HEALTH NEW ZEALAND LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
MARINE POLYMER TECHNOLOGIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDLINE
 
SUBSTANTIALLY EQUIVALENT
 3
MEDLINE INDUSTRIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
MEDTRADE PRODUCTS LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
MILLIKEN HEALTHCARE PRODUCTS, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
MOLNLYCKE HEALTH CARE
 
SUBSTANTIALLY EQUIVALENT
 1
MOLNLYCKE HEALTH CARE US LLC
 
SUBSTANTIALLY EQUIVALENT
 2
NANOFIBER SOLUTIONS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
NAWA USA, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
NEXT SCIENCE, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
OCULUS INNOVATIVE SCIENCES
 
SUBSTANTIALLY EQUIVALENT
 7
PERMEADERM, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
POLYMEDICS INNOVATIONS GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
POLYNOVO BIOMATERIALS PTY LTD
 
SUBSTANTIALLY EQUIVALENT
 2
PURICORE INC.
 
SUBSTANTIALLY EQUIVALENT
 2
ROCHAL INDUSTRIES LLC
 
SUBSTANTIALLY EQUIVALENT
 2
ROSS A. DEARDORFF
 
SUBSTANTIALLY EQUIVALENT
 1
SAM MEDICAL PRODUCTS
 
SUBSTANTIALLY EQUIVALENT
 1
SIMPLE SCIENCE, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
SONOMA PHARMACEUTICALS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
SYNEDGEN INC.
 
SUBSTANTIALLY EQUIVALENT
 1
THE HYMED GROUP CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
THEO MANUFACTURING BV
 
SUBSTANTIALLY EQUIVALENT
 1
VALEANT PHARMACEUTICALS
 
SUBSTANTIALLY EQUIVALENT
 1
VIRCHOW BIOTECH PVT LTD
 
SUBSTANTIALLY EQUIVALENT
 1
VIRCHOW BIOTECH PVT. LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
VOMARIS INNOVATIONS INC.
 
SUBSTANTIALLY EQUIVALENT
 1
W.L. GORE & ASSOCIATES,INC
 
SUBSTANTIALLY EQUIVALENT
 1
Z-MEDICA, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
Device Problems
Adverse Event Without Identified Device Or Use Problem
 225
Delivered As Unsterile Product
 93
Device Contamination With Chemical Or Other Material
 88
Unsealed Device Packaging
 78
Device Operates Differently Than Expected
 65
Patient-Device Incompatibility
 25
Device Packaging Compromised
 22
Use Of Device Problem
 21
Appropriate Term/Code Not Available
 20
Failure To Adhere Or Bond
 20
Packaging Problem
 19
Improper Or Incorrect Procedure Or Method
 17
Product Quality Problem
 16
Difficult To Remove
16
Insufficient Information
 16
Sticking
 12
Increased Sensitivity
 12
Device Handling Problem
 10
Missing Value Reason
 9
Tear, Rip Or Hole In Device Packaging
 9
Human-Device Interface Problem
 7
Material Fragmentation
 7
Defective Device
 6
Shelf Life Exceeded
 5
Manufacturing, Packaging Or Shipping Problem
 5
No Apparent Adverse Event
 5
Material Frayed
 5
Contamination During Use
 4
Material Integrity Problem
 4
Device Expiration Issue
 4
Hole In Material
 4
Protective Measures Problem
 4
Material Separation
 4
Device Markings / Labelling Problem
 3
Material Discolored
 3
Material Disintegration
 2
Expiration Date Error
 2
Increase In Suction
 2
Deformation Due To Compressive Stress
2
Torn Material
 2
Off-Label Use
 2
Patient Device Interaction Problem
 2
Device Contaminated During Manufacture Or Shipping
 2
Detachment Of Device Component
 1
Leak / Splash
 1
Device Emits Odor
 1
Failure To Disinfect
1
Difficult To Open Or Remove Packaging Material
 1
Inadequate User Interface
 1
Nonstandard Device
 1
Microbial Contamination Of Device
1
Failure To Align
 1
Collapse
 1
Moisture Or Humidity Problem
 1
Spring Loading Mechanism
 1
Delamination
 1
Physical Property Issue
 1
Particulates
 1
Suction Problem
 1
Component Missing
1
Structural Problem
 1
Increase In Pressure
 1
Device Reprocessing Problem
 1
Problem With Sterilization
 1
Infusion Or Flow Problem
 1
Illegible Information
 1
Total Device Problems 902
Recalls
Manufacturer Recall Class Date Posted
1
Advanced Medical Solutions Ltd.
 II Sep-02-2016
2
Anika Therapeutics, Inc.
 II Jul-11-2018
3
Bard Access Systems
 II Dec-01-2014
4
CareFusion 303, Inc.
 II Mar-24-2016
5
Conseal International, Inc.
 II May-03-2018
6
Coreva Health Science LLC
 II May-30-2015
7
Integra LifeSciences Corp.
 II May-04-2018
8
Medical Action Industries Inc
 II Mar-02-2016
9
Oculus Innovative Sciences, Inc.
 II Dec-14-2016
10
TZ Medical Inc.
 II Nov-19-2015
11
TZ Medical Inc.
 II Nov-18-2015
12
TZ Medical, Inc.
 II Oct-21-2016
13
Wellspring Pharmaceutical Corporation
 I Jul-29-2014
14
Z-Medica, LLC
 II Mar-08-2018
15
Z-Medica, LLC
 II Jun-19-2017
TPLC Last Update: 2019-04-02 21:14:30
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